CSA Z9918 : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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CAPNOMETERS FOR USE WITH HUMANS - REQUIREMENTS
Hardcopy , PDF
01-03-2007
English
Section 1 General
1.1 Scope
1.2 Normative references
1.3 Definitions
1.4 General requirements
1.5 General requirements for tests
1.6 Classification
1.7 Identification marking and documents
1.8 Power point
Section 2 Environmental conditions
2.1 Basic safety categories
2.2 Removable protective means
2.3 Environmental conditions
2.4 Special measures with respect to safety
2.5 Single fault condition
Section 3 Protection against electric shock hazards
3.1 General
3.2 Requirements related to classification
3.3 Limitation of voltage and/or energy
3.4 Enclosures and protective covers
3.5 Separation
3.6 Protective earthing, functional earthing and
potential equalization
3.7 Continuous leakage currents and patient auxiliary
currents
3.8 Dielectrical strength
Section 4 Protection against mechanical hazards
4.1 Mechanical strength
4.2 Moving parts
4.3 Surfaces, corners and edges
4.4 Stability in normal use
4.5 Expelled parts
4.6 Vibration and noise
4.7 Pneumatic and hydraulic power
4.8 Suspended masses
Section 5 Protection against hazards from unwanted or
excessive radiation
5.1 X-radiation
5.2 Alpha, beta, gamma, neutron radiation and other
particle radiation
5.3 Microwave radiation
5.4 Light radiation (including lasers)
5.5 Infrared radiation
5.6 Ultraviolet radiation
5.7 Acoustical energy (including ultrasonics)
5.8 Electromagnetic compatibility
Section 6 Protection against hazards of ignition of
flammable anaesthetic mixtures
6.1 Locations and basic requirements
6.2 Marking, accompanying documents
6.3 Common requirements for category AP and category
APG equipment
6.4 Requirements and tests for category AP equipment,
and parts and components
6.5 Requirements and tests for category APG equipment,
and parts and components
Section 7 Protection against excessive temperatures and
other safety hazards
7.1 Excessive temperatures
7.2 Fire prevention
7.3 Overflow, spillage, leakage, humidity, ingress of
liquids, cleaning, sterilization and disinfection
7.4 Pressure vessels and parts subject to pressure
7.5 Human error
7.6 Electrostatic charges
7.7 Materials in applied parts in contact with the
body of the patient
7.8 Interruption of power supply
Section 8 Accuracy of operating data and protection
against hazardous output
8.1 Accuracy of operating data
Section 9 Abnormal operation and fault conditions;
environmental tests
9.1 Abnormal operation and fault conditions
9.2 Environmental tests
Section 10 Constructional requirements
10.1 General
10.2 Enclosures and covers
10.3 Components and general assembly
10.4 Mains parts, components and layout
10.5 Protective earthing - Terminals and connections
10.6 Construction and layout
Section 11 Additional requirements specific to capnometers
Provides safety requirements for capnometers intended for use with adults, children and neonates.
DocumentType |
Standard
|
Pages |
45
|
PublisherName |
Canadian Standards Association
|
Status |
Superseded
|
SupersededBy |
Standards | Relationship |
ISO 9918:1993 | Identical |
CSA C22.2 No. 601.2.13 : 0 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF ANAESTHETIC MACHINES |
ISO 3744:2010 | Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane |
ISO 9703-1:1992 | Anaesthesia and respiratory care alarm signals Part 1: Visual alarm signals |
IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
ISO 5356-1:2015 | Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets |
ISO 5356-2:2012 | Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors |
IEC 60651:1979+AMD1:1993+AMD2:2000 CSV | Sound level meters |
IEC 60801-2:1991 | Electromagnetic compatibility for industrial-process measurement and control equipment - Part 2: Electrostatic discharge requirements |
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